The Conversation Begins: Recap from Day One of FDA’s LDT Regulatory Meeting
Welcome to Hyattsville, MD, where we have just completed day one of FDA’s two day “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs). The session was civil, well-organized and largely devoid of surprises. It did, however, mark the official kick-off of the FDA’s highly publicized decision to develop a “risk-based application of oversight” for all LDTs.
If you’re interested in the details of what was said and by whom you’ll find links at the bottom to all of the relevant transcripts, video feeds and Twitter coverage. For my part, here are the three key take-away points from day one:
Timing. Last week I wrote that it was unlikely that this meeting, or any of the other myriad regulatory and legislative proposals for LDT regulation, would produce a significant shift in the legal and regulatory landscape any time soon. One day of FDA meetings has done nothing to change that opinion.
Evaluating the NIH’s New Genetic Testing Registry
This morning the NIH announced plans to create a publicly accessible registry of genetic tests. The Genetic Testing Registry (GTR) is expected to be available in 2011 and will contain information voluntarily submitted by genetic test providers. The news is significant and carries implications for clinical genetic testing laboratories, personal genomics service providers and individual purchasers of genetic tests.
Many details of the GTR are yet to come, with NIH promising to “engage stakeholders – such as genetic test developers, test kit manufacturers, health care providers, patients and researchers – for their insights on the best way to collect and display test information.” While the GTR isn’t expected to launch until next year, and there is time to fill in the details, the questions and answers section of the GTR’s new website helpfully addresses several of the most important features of the registry.
This post looks at what we know about the GTR today, and considers what the GTR’s ultimate implementation might mean for the development and regulation of genetic testing. (Note that the inset orange questions, and the text that immediately follows each question, is taken directly from the GTR question and answer page.)
